ARCHITECT CORE Reagent Kit, Alinity i Anti-HBc Reagent Kit

FDA Premarket Approval P080023 S034

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval to modify the architect i1000sr probe wash with an alternate wash delivery system (awds), and to modify the architect i2000sr and alinity i with induction heating (ih).

DeviceARCHITECT CORE Reagent Kit, Alinity i Anti-HBc Reagent Kit
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantAbbott Laboratories
Date Received2021-02-09
Decision Date2021-04-22
PMAP080023
SupplementS034
Product CodeLOM 
Advisory CommitteeMicrobiology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Abbott Laboratories 100 Abbott Park Rd. ap5n-2, Dept. 09vb abbott Park, IL 60064

Supplemental Filings

Supplement NumberDateSupplement Type
P080023Original Filing
S034 2021-02-09 Real-time Process
S033 2020-03-16 Normal 180 Day Track No User Fee
S032 2020-03-16 Normal 180 Day Track No User Fee
S031
S030 2018-10-12 30-day Notice
S029 2018-07-13 30-day Notice
S028 2017-12-21 Normal 180 Day Track
S027 2015-07-16 30-day Notice
S026 2014-11-13 30-day Notice
S025 2014-09-19 30-day Notice
S024 2013-10-30 30-day Notice
S023 2013-10-28 30-day Notice
S022 2013-09-04 30-day Notice
S021 2013-02-15 30-day Notice
S020 2013-02-11 30-day Notice
S019 2012-11-19 30-day Notice
S018 2012-11-15 30-day Notice
S017 2012-11-13 30-day Notice
S016 2012-11-01 30-day Notice
S015 2012-08-03 30-day Notice
S014 2012-03-22 30-day Notice
S013 2012-03-15 30-day Notice
S012 2011-11-23 Special (immediate Track)
S011 2011-10-28 135 Review Track For 30-day Notice
S010 2011-10-28 30-day Notice
S009 2011-05-25 30-day Notice
S008 2011-05-04 Normal 180 Day Track No User Fee
S007 2011-04-18 30-day Notice
S006 2011-02-17 Normal 180 Day Track No User Fee
S005 2010-12-28 135 Review Track For 30-day Notice
S004 2010-12-22 Special (immediate Track)
S003 2010-11-01 Normal 180 Day Track No User Fee
S002 2010-06-22 Normal 180 Day Track No User Fee
S001 2009-06-19 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00380740011123 P080023 001
00380740011116 P080023 001
00380740011109 P080023 001
00380740136666 P080023 028
00380740136659 P080023 028
00380740136642 P080023 028
00380740136635 P080023 028

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